Evidence map›Paper›PMID 25450031›Full record

ArticleClinical genitourinary cancer2015

A phase I study of everolimus and docetaxel in patients with castration-resistant prostate cancer.

Kevin D Courtney, Judith B Manola, Aymen A Elfiky, Robert Ross, William K Oh, Jeffrey T Yap, Annick D Van den Abbeele, Christopher W Ryan, Tomasz M Beer, Massimo Loda and 3 more

Open access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Clinical genitourinary cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.

  1. Pooled it
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  3. Prospective evaluation of [European journal of nuclear medicine and molecular imaging · 2016
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  4. Targeting the PI3K/AKT/mTOR signaling pathway in prostate cancer: Molecular dysregulation, therapeutic advances, and future directions.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2026
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  18. GRP78 and α2-macroglobulin are new promising targets for metastatic castrate-resistant prostate cancer treatment.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2015
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 4 institutions in 1 country.

Kevin D CourtneyMedical Oncology, Dana-Farber Cancer Institute and Internal Medicine, Harvard Medical School, Boston, MA.
Judith B ManolaDepartment of Biostatistics and Computational Biology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA.
Aymen A ElfikyMedical Oncology, Dana-Farber Cancer Institute and Internal Medicine, Harvard Medical School, Boston, MA.
Robert RossMedical Oncology, Dana-Farber Cancer Institute and Internal Medicine, Harvard Medical School, Boston, MA.
William K OhMedical Oncology, Dana-Farber Cancer Institute and Internal Medicine, Harvard Medical School, Boston, MA.
Jeffrey T YapDepartment of Imaging, Dana-Farber Cancer Institute, Department of Radiology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
Annick D Van den AbbeeleDepartment of Imaging, Dana-Farber Cancer Institute, Department of Radiology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
Christopher W RyanKnight Cancer Institute at Oregon Health and Science University, Portland, OR.
Tomasz M BeerKnight Cancer Institute at Oregon Health and Science University, Portland, OR.
Massimo LodaMedical Oncology, Dana-Farber Cancer Institute and Internal Medicine, Harvard Medical School, Boston, MA; Department of Pathology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
Carmen PrioloMedical Oncology, Dana-Farber Cancer Institute and Internal Medicine, Harvard Medical School, Boston, MA.
Philip KantoffMedical Oncology, Dana-Farber Cancer Institute and Internal Medicine, Harvard Medical School, Boston, MA.
Mary-Ellen TaplinMedical Oncology, Dana-Farber Cancer Institute and Internal Medicine, Harvard Medical School, Boston, MA. Electronic address: Mary_Taplin@dfci.harvard.edu.
Dana-Farber Cancer Institute · USHarvard University · USOregon Health & Science University · USBrigham and Women's Hospital · US

Funding

Understanding the origins of rapid recurrence of pancreatic cancer after resectionP30CA069533 · NCI · OREGON HEALTH & SCIENCE UNIVERSITY · PI Luiz Eduardo Bertassoni · 1997 to 2026
$60.5M
NCI NIH HHS P30 CA069533
6 · The paper itself

Abstract

backgroundThe PTEN tumor suppressor is frequently lost in CRPC, with activation of Akt-mTOR signaling, driving growth. We conducted a phase I trial of the mTOR inhibitor, everolimus, and docetaxel in CRPC. PATIENTS AND

methodsEligible patients had progressive, metastatic, chemotherapy-naive CRPC. Patients received everolimus 10 mg daily for 2 weeks and underwent a restaging FDG-PET/computed tomography scan. Patient cohorts were subsequently treated at 3 dose levels of everolimus with docetaxel: 5 mg to 60 mg/m(2), 10 mg to 60 mg/m(2), and 10 mg to 70 mg/m(2). The primary end point was the safety and tolerability of combination therapy.

resultsAccrual was 4 patients at level 1, 3 patients at level 2, and 8 patients at level 3. Common toxicities were hematologic and fatigue. Serum concentrations of everolimus when administered with docetaxel were 1.5 to 14.8 ng/mL in patients receiving 5 mg everolimus and 4.5 to 55.4 ng/mL in patients receiving 10 mg everolimus. Four patients had partial metabolic response (PMR) using FDG-PET, 12 had stable metabolic disease, and 2 had progressive metabolic disease after a 2-week treatment with everolimus alone. Five of 12 evaluable patients experienced a prostate-specific antigen (PSA) reduction ≥ 50% during treatment with everolimus together with docetaxel. All 4 patients with a PMR according to PET imaging experienced a PSA reduction in response to everolimus with docetaxel, and 3 of 4 had PSA declines ≥ 50%.

conclusionEverolimus 10 mg daily and docetaxel 60 mg/m(2) was safe in CRPC patients and these were the recommended doses in combination. FDG-PET response might serve as a biomarker for target inhibition by mTOR inhibitors.

Indexed as

AgedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorDocetaxelDrug Administration ScheduleEverolimusFluorodeoxyglucose F18HumansMaleMaximum Tolerated DoseMiddle AgedPositron-Emission TomographyProstatic Neoplasms, Castration-ResistantTaxoidsTreatment OutcomeAntineoplastic AgentsBiomarkers, TumorDocetaxelEverolimusFluorodeoxyglucose F18TaxoidsmTORPI3KPositron emission tomographyProstatic adenocarcinomaPTEN

Identifiers

PMID25450031
PMCPMC4418946
OpenAlexW2037180670

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.